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Verfasst von:Medem, Anna von [VerfasserIn]   i
 Seidling, Hanna [VerfasserIn]   i
 Kaltschmidt, Jens [VerfasserIn]   i
 Metzner, Michael [VerfasserIn]   i
 Czock, David [VerfasserIn]   i
 Haefeli, Walter E. [VerfasserIn]   i
Titel:Definition of variables required for comprehensive description of drug dosage and clinical pharmacokinetics
Verf.angabe:Anna v. Medem, Hanna M. Seidling, Hans-Georg Eichler, Jens Kaltschmidt, Michael Metzner, Carina M. Hubert, David Czock, Walter E. Haefeli
E-Jahr:2017
Jahr:14 February 2017
Umfang:9 S.
Teil:volume:73
 year:2017
 number:5
 pages:633-641
 extent:9
Fussnoten:Published online: 14 February 2017 ; Gesehen am 22.10.2018
Titel Quelle:Enthalten in: European journal of clinical pharmacology
Ort Quelle:Berlin : Springer, 1968
Jahr Quelle:2017
Band/Heft Quelle:73(2017), 5, Seite 633-641
ISSN Quelle:1432-1041
Abstract:Purpose: Electronic clinical decision support systems (CDSS) require drug information that can be processed by computers. The goal of this project was to determine and evaluate a compilation of variables that comprehensively capture the information contained in the summary of product characteristic (SmPC) and unequivocally describe the drug, its dosage options, and clinical pharmacokinetics. Methods: An expert panel defined and structured a set of variables and drafted a guideline to extract and enter information on dosage and clinical pharmacokinetics from textual SmPCs as published by the European Medicines Agency (EMA). The set of variables was iteratively revised and evaluated by data extraction and variable allocation of roughly 7% of all centrally approved drugs. Results: The information contained in the SmPC was allocated to three information clusters consisting of 260 variables. The cluster “drug characterization” specifies the nature of the drug. The cluster “dosage” provides information on approved drug dosages and defines corresponding specific conditions. The cluster “clinical pharmacokinetics” includes pharmacokinetic parameters of relevance for dosing in clinical practice. A first evaluation demonstrated that, despite the complexity of the current free text SmPCs, dosage and pharmacokinetic information can be reliably extracted from the SmPCs and comprehensively described by a limited set of variables. Conclusion: By proposing a compilation of variables well describing drug dosage and clinical pharmacokinetics, the project represents a step forward towards the development of a comprehensive database system serving as information source for sophisticated CDSS.
DOI:doi:10.1007/s00228-017-2214-6
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

Volltext ; Verlag: http://dx.doi.org/10.1007/s00228-017-2214-6
 Volltext: https://doi.org/10.1007/s00228-017-2214-6
 DOI: https://doi.org/10.1007/s00228-017-2214-6
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:Clinical decision support system (CDSS)
 Dosage
 Drug label
 Electronic summary of product characteristics (e-SmPC)
 Pharmacokinetics
 Summary of product characteristics (SmPC)
K10plus-PPN:1582144141
Verknüpfungen:→ Zeitschrift

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